Clinical Trial: Development of head stabilization methods based on the mechanisms of head displacement during brain MRI (Japan)

Tokyo, Sept. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062941) titled 'A study of head movement during MRI to develop methods for keeping the head still' on Sept. 16.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Fukushima Medical University

Condition: Condition - Not applicable Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To quantitatively characterize head movement during brain MRI and inform the development of head stabilization methods and devices. This preliminary study in one healthy adult will explore head displacement with and without a stabilization device and across device positions and stabilization methods, and assess the feasibility of MRI acquisition and image analysis. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - One healthy adult will undergo repeated cine brain MRI under conditions without a head stabilization device and with the device at different positions and using different stabilization methods. The participant will perform mild head movements in specified directions during each acquisition.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1.Healthy adults who can undergo brain MRI and understand instructions for mild head movement during imaging. 2. Individuals who provide written informed consent to participate in the study. Key exclusion criteria - 1. Individuals with claustrophobia. 2. Individuals with an active implantable medical device or a similar implanted device. 3. Individuals with a history of head surgery. 4. Individuals who have difficulty maintaining the required position or performing mild head movements during imaging. Target Size - 1

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 07 Month 20 Day Date of IRB - 2026 Year 09 Month 08 Day Anticipated trial start date - 2026 Year 09 Month 15 Day Last follow-up date - 2027 Year 09 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072062

Disclaimer: Curated by HT Syndication.